This page contains details of recent regulatory decisions and general news relating to the regulation of biocidal products.
Information on significant historical regulatory decisions can be found in our archive.
In August 2012 HSE requested comments from stakeholders on proposals for environmental risk mitigation measures to be imposed in the UK on rodenticide bait products based on difethialone, difenacoum, bromadiolone, brodifacoum and flocoumafen. These proposals were sent to stakeholders by email and also made available on the HSE website. HSE would like to thank those stakeholders who were able to provide responses. A summary of the fifty responses submitted by stakeholders is available for download.
The next stage of the stakeholder engagement process will be to hold a meeting on Tuesday 23rd April in the Merseyside area. We hope that representatives of the responding stakeholder organisations will be able to attend this meeting. More details will follow shortly.
Published 15 March 2013
The EU Commission has published BPD Annex I/IA Inclusion Directives for the following active substances:
These active substances will be Included in Annex I of the BPD on 1st February 2015. Applications for product authorisation or mutual recognition must be submitted by 1st February 2015.
Links to previous Annex I/IA Inclusion Decisions can be found on the EU Commission's website.
Published 1 March 2013
HSE is seeking your views on proposed fees regulations to support the EU Regulation 528/2012 on placing on the market and use of biocidal products.
Placing on the market and use of biocidal products is currently regulated at EU level through Directive 98/8/EC (the 'Biocidal Products Directive' or BPD). The BPD will replaced on 1st September 2013 by a new directly applicable EU Regulation on placing on the market and use of biocidal products (Regulation EU No 528/2012).
New domestic regulations will be required to support certain parts of the EU Regulation. A consultation has already taken place on regulations to introduce enforcement measures and penalties for the EU Regulation, consolidating these with related provisions on classification and labelling of chemicals and export and import of hazardous chemicals.
Domestic regulations are also required to enable HSE to continue charging fees to recover its costs under the new EU Regulation. The fee regulations are the subject of this consultation.
The proposed fees regulations will allow HSE to recover its full costs for the services it provides under Regulation in line with Annex 6.2 of HM Treasury's document, Managing Public Money.
This consultation begins on 25th February 2013 and ends on 22nd March 2013.
You can see the consultation document and find out how to respond by going to the HSE consultation pages.
Published 22 February 2013
The EU Commission has published BPD Annex I/IA Inclusion Directives for the following active substances:
These active substances will be Included in Annex I of the BPD on 1st February 2015. Applications for product authorisation or mutual recognition must be submitted by 1st February 2015.
Links to previous Annex I/IA Inclusion Decisions can be found on the EU Commission's website.
Published 22 February 2013
The EU Commission has published the Ninth Biocidal Products Directive (BPD) Non Inclusion Decision, dated 14 February 2013, in the Official Journal of the European Union. Biocidal products containing the active substances in the list product type, shall no longer be placed on the market with effect from 1 February 2014
Companies must manage the supply of the affected product to ensure there will be none remaining in the EU supply chain by the Non Inclusion date (1 February 2014).
Published 22 February 2013
HSE is aware of recent concerns raised in the press regarding the outdoor use of second generation anticoagulant rodenticides (SGARs) under the Biocidal Products Directive (BPD).
There is no outright ban on the use of rodenticides outdoors. As products move across from approvals under the Control of Pesticides Regulations (COPR) to authorisations under the BPD the current intention is that SGARs will be able to be used outdoors, but restricted to use 'in and around buildings' rather than broader open area use. HSE is however considering the results of the recent ‘Stakeholder Engagement’ we carried out on this issue and this position may therefore be subject to change.
As different SGARs are moving across to authorisation under the BPD at different times, some products are now authorised under the BPD and some are still marketed under their older COPR approval which may have allowed or prohibited outdoor use depending on the active substance in the product. Each product should therefore continue be used in accordance with the conditions on the product label and users should always check the label before using the product – if you are unsure about the approval/authorisation status of a product, contact HSE [link to PA account?].
The new restrictions on the particular rodenticide products that have already been authorised under the BPD need not have any negative impact on the control of rat populations as currently other products and methods are available for rodent control in open areas. It is also important to be clear that rodenticides should only form part of a broader strategy for rodent control.
HSE recognises that outdoor use of SGARs is a complex issue and there may not be a solution that will be entirely acceptable to everyone, and is continuing to engage with stakeholders so the best way forward can be found, balancing the need to control rodents with the risks of unintended poisoning of other wildlife.
Published 22 February 2013
Where an active substance has not been supported for review, the Biocidal Products Directive's '5th Review Regulation' (Regulation (EC) 1451/2007) allows Member States to apply to the European Commission for an extension of the deadline for the removal from the market of that substance, where they consider that the substance is essential in their territory.
Such an application can be made when the Member State considers the substance is essential for reasons of health, safety, protection of cultural heritage or is critical for the functioning of society, and that there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health.
The UK has made such an 'essential use' application to the Commission for the use of copper in legionella control in Product Types 2 and 5.
The Commission has made the application available on Circabc in order to start the 60-day commenting period, ending on 20 April 2013.
Information on essential use derogations can also be found on the Commission's website.
You may submit comments in writing direct to the Commission (not to HSE), to the following address by 20th April 2013:
Directorate-General Environment
Unit B-4, Office Bu-9, 6-163
B-1049 Brussels
ENV-Biocides@ec.europa.eu
Further information on the non-inclusion decision for copper and the issue in relation to legionella control is available on the Legionella section of the HSE website
Published 19th February 2013
The EU Commission has published BPD Annex I/IA Inclusion Directives for the following active substances:
These active substances will be Included in Annex I of the BPD on 1st October 2014. Applications for product authorisation or mutual recognition notices of intention must be submitted by 1st October 2014.
Links to previous Annex I/IA Inclusion Decisions can be found on the EU Commission's website.
Published 12 December 2012
The EU Commission has published a new Biocidal Products Directive Non Inclusion Decision, dated 23 November 2012, in the Official Journal of the European Union, for bifenthrin (product type 18). Biocidal products containing bifenthrin (product type 18) shall no longer be placed on the market with effect from 1 May 2013.
Companies must manage the supply of the affected product to ensure there will be none remaining in the EU supply chain by the Non Inclusion date (1 May 2013).
More on the Non Inclusion Decision
Published 12 December 2012
The EU Commission has published a new Biocidal Products Directive Decision, dated 26 November 2012, in the Official Journal of the European Union, to amend the entry for disodium tetraborate (product type 8).
This decision amends the CAS number for disodium tetraborate (product type 8) as they were incorrectly list in the original assessment report.
Published 12 December 2012
The EU Commission has published a new Biocidal Products Directive Decision, dated 26 November 2012, in the Official Journal of the European Union, to amend certain headings of Annex I to BPD.
This decision amends the following headings
Published 12 December 2012
The following active substances will be Included onto Annex I/IA of the Biocidal Products Directive (BPD) on the 1 July 2013.
All products approved under the Control of Pesticides Regulations (COPR) affected by the above Annex I/IA Inclusion decisions will be issued with notices to revoke COPR approval with a cut off date of 30 June 2013.
All affected companies are reminded that they must apply for authorisation/registration under the Biocidal Products Regulations (BPR) in order to keep their biocidal products on the UK market after the Annex I/IA Inclusion date (1 July 2013).
Companies who decide not to submit a BPR product authorisation application must manage the supply of the affected product to ensure there will be none remaining in the EU supply chain by the Annex I/IA Inclusion date (1 July 2013). However under BPR a phase-out period can be requested to allow them time to dispose of UK stocks appropriately.
Published 19 October 2012
The EU Commission has published a new Commission Decision, dated 20 August 2012, which sets a new deadline for the submission of dossiers for the following substances
Any company wishing support these substance(s) under the 14-year work programme referred to in Article 16(2) of Biocidal Products Directive must submit a dossier to the assigned Competent Authority by 30 September 2013.
Published 19 October 2012
The EU Commission has published BPD Annex I/IA Inclusion Directives for the following active substances:
These active substances will be Included in Annex I of the BPD on 1st February 2014. Applications for product authorisation or mutual recognition notices of intention must be submitted by 1st February 2014.
Links to previous Annex I/IA Inclusion Decisions can be found on the EU Commission's website.
Published 7 September 2012 (updated 22 February 2013)
The following active substance will be Included onto Annex I of the Biocidal Products Directive (BPD) on the 1 May 2013.
Creosote (PT8 - Wood Preservatives)
All products approved under the Control of Pesticides Regulations (COPR) affected by the above Annex I Inclusion decisions will be shortly issued with notices to revoke COPR approval with a cut off date of 30 April 2013.
All affected companies are reminded that they must apply for authorisation under the Biocidal Products Regulations (BPR) in order to keep their biocidal products on the UK market after the Annex I Inclusion date (1 May 2013).
Companies who decide not to submit a BPR product authorisation application must manage the supply of the affected product to ensure there will be none remaining in the EU supply chain by the Annex I Inclusion date (1 May 2013). However under BPR a phase-out period can be requested to allow them time to dispose of UK stocks appropriately.
Please note that this Annex I Inclusion decision allows each Member State to authorise creosote for a given use where it judges that no appropriate alternatives are available, based on an analysis of the feasibility of substitution provided by the applicant.
When applying for product authorisations the applicant must provide information/data to meet the conditions as outlined in the Inclusion Directive.
Published 3 August 2012
The EU Commission has published BPD Annex I/IA Inclusion Directives for the following active substances:
These active substances will be Included in Annex I of the BPD on 1st May 2014. Applications for product authorisation or mutual recognition notices of intention must be submitted by 1st May 2014.
Links to previous Annex I/IA Inclusion Decisions can be found on the EU Commission's website.
Published 15 May 2012 (updated 22 February 2013)
The EU Commission has published BPD Annex I/IA Inclusion Directives for the following active substances:
These active substances will be Included in Annex I of the BPD on 1st February 2014. Applications for product authorisation or mutual recognition must be submitted by 1st February 2014.
Links to previous Annex I/IA Inclusion Decisions can be found on the EU Commission's website
Published 21 February 2012 (updated 22 February 2013)
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